JP2016540879A - Method for processing perfluoropolymer material - Google Patents

Abstract

The present invention relates to a method for processing perfluoropolymer materials and the use of reaction products in different potential applications such as in the field of medical devices.

Description

  The present invention relates to a method for processing perfluoropolymer materials and the use of resultant products in different potential applications such as in the field of medical devices.

  Perfluoropolymer materials or perfluoroelastomeric materials are well known in the art. This material also has a high level of chemical resistance (fluid resistance, base-resistance, dielectric properties, and high temperature resistance) It is known to have plasma resistance, compression set resistance, and effective mechanical properties. In addition, compression set (compression set) is the property of the elastomer material (elastomeric material) which maintains the state distorted without removing the compression load (compressive load) to deform | transform, and returning to the original shape, The value of compressive strain is expressed as a percentage of the original deflection where the material did not return. Because of these properties, this material has many potential and practical applications. For example, perfluoropolymer materials are not only in the semiconductor industry utilizing plasma resistance, but also for use as corrosive chemicals or critical operations for use as molded parts that can withstand deformation. It can also be used as elastomeric seals where the seal or gasket is exposed to extreme operating conditions. The main market (80%) is essentially its use as solvent resistance. The aerospace industry applications of these compositions range from oxidizer resistant components to the sealing of commercial and military jet engines that operate in high temperature environments.

  FFKM gums are elastomer precursors and are precisely defined as perfluoroelastomers (ie, fully fluorinated and free of hydrogen atoms).

  FFKM elastomers highly fluorinated to 71-72% have a fluorination level approximately equivalent to polytetrafluoroethylene (PTFE) having a theoretical fluorination level of 76%. This is inferior to 62-68% of non-fully fluorinated fluoroelastomers. This means, for example, that Freudenberg's perfluoroelastomer Simriz (Simriz is a registered trademark) is highly resistant to reaction media, solvents, acids and alkalis over a wide temperature and pressure range. Means. Since Simlitz's chemical resistance is highly versatile, almost all media can be statically sealed.

  Other perfluoro compositions known in the art include those sold under the trade name Fluorinert®. Fluorinate is an electrically insulating and stable fluorocarbon-based fluid, and is mainly used as a coolant liquid for electronic devices. Different boiling points can be given to different molecular structures, so that the composition remains in a liquid state in a “single-phase” application, or the composition liquid is evaporatively cooled. Can be used in "two-phase" applications that boil to remove additional heat via cooling. One example of these fluorinates is what is commonly called FC-72, or perfluorohexane (C6F14). Since perfluorohexane has a boiling point of 56 ° C., it is used for low temperature heat transfer applications. Another example is FC-75, perfluoro (2-butyl-tetrahydrofurane). Some fluids, such as FC-70, are sold under the trade name Fluorinate, which can withstand temperatures up to about 215 ° C., as are fluids bearing the trademark FLUTEC®. is there.

  However, perfluoroelastomer materials are expensive. As a result, the cost of materials and parts such as seals and gaskets is significantly higher than those made of other elastomeric materials.

  Thus, while the properties of perfluoroelastomers are highly desirable, their use tends to be limited, and thus an improved method of processing pearl fluoroelastomer materials that can produce perfluoroelastomer end products for end use Development is desired.

WO03 / 0778516

  Conventional methods for processing perfluoroelastomer materials are disclosed in WO 03/0778516 by Greene, Tweed of Delaware, Inc., and CuMedica Group PLC, Delaware. This method involves mixing a perfluoroelastomer material with two perfluorosolvents, one perfluorosolvent having a high boiling point and the other having a low boiling point. The boiling point of the latter solvent is low enough that no heat or energy needs to be applied for the solvent to evaporate, and its evaporation can be done manually, ie, using a putty knife or similar tool. Promoted by increasing the area. Add ceramic or metal balls to facilitate mixing, pour the mixture onto a tray or other flat surface (metal or plastic), remove the low boiling point solvent, and deliberately become part of the mixture Leave a solvent with a high boiling point. When the low boiling point solvent is removed, the mixture solidifies and becomes a dough-like material on the tray. This is then manually chopped into pieces and fed to a mandrel in a compression mold. Here the material is fully cured. The method described in WO 03/075516 is exclusively intended for molding perfluoroelastomer materials in a mold by compression molding techniques.

Therefore, according to the present invention, a method for treating a perfluoropolymer material is provided, the method comprising the following steps.
i) dissolving one or more uncured perfluoropolymer materials in a solvent comprising one or more liquid perfluorosolvents to form a solution;
ii) Optionally, one or more porogens and / or one or more functional additives are added to the solution formed in step (i) and the mixture is Forming, and
iii) applying the solution or mixture formed in steps (i) and (ii) to the substrate to form a partial or continuous one or more deposited layers on the substrate;
iv) applying a predetermined amount of energy to the substrate or the one or more deposited layers to at least partially remove the solvent from the one or more deposited layers;
v) curing the perfluoropolymer material in the one or more deposited layers to form a perfluoroelastomeric product;
vi) optionally removing one or more porogens from the perfluoroelastomer product.

  In contrast to the method detailed in WO 03/075516, the present invention cures the perfluoropolymer material on the same substrate on which the perfluoropolymer material was first deposited in step (iii), and Requires energy to remove the solvent. The advantage of the present invention is that the perfluoropolymer material is deposited and shaped, whereas the ease of manual handling of the perfluoropolymer material, which requires a metal tray and mandrel in WO 03/075516, And only one single substrate to cure is required, whereas only a single layer is allowed in WO03 / 0778516, multiple stacks can be easily deposited on a substrate, 2 in WO03 / 0778516 Whereas a solvent is required, the process of the present invention includes that it can be carried out using only one solvent. Furthermore, the present invention adds or attaches a permanent attachment to expanded polytetrafluoroethylene (ePTFE) or other suitable non-temporary (ie molded or formed) substrate. In addition, direct heating can be used.

  Perfluoroelastomer products made in accordance with the present invention include, for example, implants, grafts, insertable medical devices, cardiovascular prostheses, grafts, synthetic lattices. ) (Tissue engineered products using other components that function as scaffolds for human or animal cell growth within the scaffold) Other components of humans or animals for medical purposes It can have many different uses and applications, such as body use. They can also be applied to internal cores and outer sheaths for sealing members such as O-rings, gaskets or the like.

  Conventional typical elastomers or plastics used in such medical applications include in particular polyurethanes, PTFE, expanded PTFE and silicones. These conventional materials, for example, generally have sufficient strength, for example, while silicone has many acceptable properties, but exhibits poor tear strength and suture pull-out resistance, for example. And the relevant mechanical properties in the body are not sufficient.

  While polyurethane has excellent physical properties for some applications, it may exhibit degradation, typically hydrolytic degradation, that can lead to catastrophic failure of critical medical devices. Expanded PTFE is compatible and has excellent biocompatibility, but is not sufficiently expandable and is acceptable for some applications such as hernia repair or pericardial patch However, it has cloth-like properties that are not ideal for many other applications that require distensibility and elastic properties such as use in blood vessels. Have.

  As used herein, a “perfluoroelastomer” can be any cured elastomeric material produced by curing a perfluoroelastomer material as defined herein, causing curing. It is intended to include a curable perfluoropolymer having a cross-linking group. Perfluoroelastomers are substantially fully fluorinated, preferably fully fluorinated with respect to carbon atoms on the backbone of the perfluoropolymer. Of course, based on this disclosure, residual hydrogen may be present in the perfluoroelastomer in the crosslink due to the use of hydrogen in functional crosslinkable groups in certain perfluoroelastomer materials. Perfluoroelastomers are generally cross-linked polymeric structures. Perfluoropolymers used in perfluoroelastomer materials to cure to form perfluoroelastomers are formed by polymerizing one or more perfluorinated monomers, one of which is cured. Preference is given to a perfluorinated curesite monomer having a functional group enabling it. One or more perfluoropolymers and preferably at least one curing agent are mixed in a perfluoroelastomer material that is a cross-linked elastomer product or perfluoroelastomer.

  As used herein, “perfluoroelastomeric material” or “perfluoropolymer material” refers to a functionality that allows at least one perfluorinated at least one cure. A polymeric material comprising a curable perfluoropolymer produced by polymerizing one or more perfluorinated monomers including a monomer having a group. Such materials are commonly referred to as FFKMs or referred to herein, as defined by American Standardized Testing Methods (ASTM).

  Specific examples of perfluoropolymer materials that can be used in accordance with the present invention include, but are not limited to, copolymers of one or more different perfluorinated and at least one fluorine-containing ethylenically unsaturated monomer. Is included. This is for example tetrafluoroethylene (TFE), hexafluoropropylene (HFP) and perfluoroalkyl vinyl ethers (PAVEs). These include linear or branched alkyl groups and ether linkages such as perfluoro (methyl vinyl ether), perfluoro (ethyl vinyl ether), perfluoro (propyl vinyl ether), perfluoroalkoxy vinyl ether and other similar compounds. .

  In general, the perfluoropolymer used is a terpolymer of TFE, PAVE, and at least one perfluorinated cure site monomer containing functional groups that allow the terpolymer to crosslink. Suitable cure site monomers include, among others, those having a functional group of cyano cure site, bromo, iodo or pentafluorophenoxy. Such monomers are well known in the art. Curing agents used in various perfluoroelastomer compositions include bisphenols and their derivatives, tetraphenyl tin and peroxide-based curing systems. In addition, the perfluoropolymer may be cured using radiation curing techniques. Such materials are well known in the art.

  Many such cured perfluoropolymers are commercially available. Preferred perfluoropolymers are those used in Chemraz® parts available from Greene, Tweed & Co., Inc. of Kulpsville, Pennsylvania, Pennsylvania. . Another preferred perfluoropolymer is E.I., located in Nemouazu, Wilmington, Delaware. Ai. Perfluoroelastomer cured Kalrez® parts and materials, commercially available from E. I. du Pont de Nemours of Wilmington, Delaware. Uncured commercial perfluoropolymers are also known and are available from Freudenberg of Germany, Simriz®, Minnesota Mining and Manufacturing, Minnesota Dyneon (registered trademark) available from Mining & Manufacturing in Minnesota, Daiel-Perfluor, registered from Daikin Industries, Ltd. in Osaka, Japan Trademark). Similar materials are available from AUSHIMONT S. in Italy. p. A (Ausimont S. p. A. in Italy).

  Preferred solvents for use in the present invention are those in which only the uncured perfluoropolymer material and / or curing agent dissolves. Most preferably, only the uncured perfluoropolymer in the perfluoroelastomer material dissolves without dissolving the porogen, filler, curing agent and other additives. More preferred solvents are those that can be used alone or in combination, special solvents specifically designed for the dissolution of perfluoropolymers, perfluorinated themselves such as liquid perfluorinated compounds. Liquids of other materials. Such solvents are known in the electronics industry. Suitable commercially available solvents include Fluorinert® available from 3M, St. Paul, Minnesota, and F2 Chemicals in Preston, UK. Preston, UK) under the trade name FLUTEC (R).

  Preferred Fluorinert® includes, for example, those sold under the trademarks FC-87, FC-84, FC-75 and FC-43. However, perfluorinated solvents, which are any known or developed solvents in which the perfluoropolymer is soluble in the perfluoroelastomer material and the porogens, fillers, curing agents and other additives are not soluble ( It is to be understood that perfluorinated solvents are preferred and may be used as within the scope of the present invention.

  In the present invention, it is possible to use one or more solvents, but typically only one solvent is required.

  Generally, the total amount of uncured perfluoropolymer material in solution is no more than about 30% by weight of the perfluorinated solvent, more typically between about 2 and about 15%. . One or more curing agents or agents are formulated in a total of about 1 to about 10 parts by weight per 100 parts by weight of perfluoropolymer material, more preferably about 1 to about 5 parts by weight.

  Once the perfluoropolymer material and curing agent are in solution, optionally one or more porogens and any additives are mixed in the solution in random order and dispersed to form a mixture. Porogens and additives that can be incorporated into the solution to form a mixture are described below. This additive is preferably present in a total amount of about 10 to about 500 parts by weight per 100 parts by weight of perfluoropolymer in the perfluoropolymer material, more preferably about 150 to 250 parts by weight.

  Dissolution and / or binding of the components in solution may be accomplished by any suitable mixing or blending technique. Prior to the dispersion of the one or more porogens and additives, the solution is preferably not heated or even heated to a temperature below the cure temperature to avoid premature curing of the elastomer.

  In general, mechanical agitation systems that move undissolved perfluoropolymer gum solids through a perfluorosolvent substantially or completely remove the perfluoropolymer from the perfluoropolymer material. A solution is established by dissolving in a fluorosolvent and used to disperse the porogen thoroughly and evenly. Either a magnetic stirrer, multi-axis mixer, roller table or ball mill can be used. Ball mills, homogenizers or similar devices can avoid the agglomeration action of porogen or other particulate additives in the mixed solution. Such blending or mixing is performed until the curing agent and porogen are thoroughly dispersed in a well-mixed solution of perfluoropolymer material and, if present, the additive is well dispersed. Should.

  The compositions of the present invention may generally comprise one or more porogens, i.e. materials that form pores in the perfluoropolymer, or materials that act to increase porosity. Typical compounds that act as porogens in the present invention include sodium chloride, salicylic acid, lactose, valine, sodium bicarbonate, sodium bicarbonate. hydrogen carbonate, calcium carbonate, glycine, polyethylene oxide, polyethylene glycol, polyethylene pyrrolidone, polyvinylpyrrolidone, polymer of fine particles (eg, polyvinyl chloride) and There are, but are not limited to, one or more compounds selected from titanium dioxide.

In general, porogens have a relatively narrow particle size distribution so that the open cells formed in the cured material are uniform in size. If this material does not initially fall into this category, it may be made to fall into this distribution by micronizing this material or otherwise using a ball mill and sieve or similar equipment. . However, it will be appreciated that if such uniformity is not desired, particle size uniformity of the pore forming material is not necessary. In preferred embodiments of the present invention, open cell porous perfluoropolymers are formed having an average pore size of about 1 to about 150 microns. For use in certain applications, the pore forming agent has an average particle size greater than 0 microns and less than 10 microns, an intermediate size of about 10 to about 50 microns, and a larger size of 50 microns. More than can be used. The intermediate size is a preferred range, for example in the use of cardiovascular prostheses.
Typical amounts of porogen are from about 10 parts to about 500 parts by weight, more preferably from about 50 parts to about 300 parts by weight per 100 parts by weight of perfluoropolymer in the perfluoropolymer material. High porogen loadings are preferred to form a highly porous matrix, eg, to achieve a porosity level (density reduction) of about 85% or more, The porogen loading can be from 50 parts to 500 parts or more per 100 parts perfluoropolymer in the perfluoropolymer material. High porosity levels (low density) can be achieved with high loadings if desired. Porogen density, particle size and amount all contribute to the basic properties of cellular materials, for example, porogen density corresponds to the change in spatial volume occupied for a given amount of porogen. Can affect the porosity. The higher the density of the material, the smaller the pore volume if the amount of porogen is the same. Furthermore, the particle size of the porogen can change the pore diameter and / or the surface area of the pores.

  In further subsequent steps, the porogen can be removed from the cured material as desired.

  In this specification, with respect to medical applications, “device” has the broadest meaning, without limitation, all types of medical devices, parts, components, artificial blood vessels. (Vascular protheses), grafts, implants, regenerative medical products, including regenerative medical products, scaffolds, synthetic spinal disks, breast prostheses and any other device Mention may be made of synthetic lattices for use in the formation of any of the following: any other devices include soft tissue, tubes, catheters, stents, Drainage tubes, synthetic dura mater, pericardial patches, cannulae, fistulas, ports and And similar ones.

  If desired, one or more curing agents may be added as part of the process of the present invention.

  According to the present invention, step (v) of the step of curing the perfluoropolymer is selected either when the perfluoropolymer is still on the substrate or when the perfluoropolymer is not on the substrate. Can be implemented automatically. Prior to the curing step, the perfluoropolymer may be removed from the substrate and cured separately.

  As mentioned above, the perfluoropolymer material may further comprise other functional materials suitable for the addition of perfluoroelastomeric compounds. These are graphite, carbon black, carbon nanotubes, clay, silicon dioxide, polymeric graphite, fluoropolymeric particulates ( For example, TFE homopolymer and copolymer micropowder), barium sulfate, silica, titanium dioxide, silver chloride, magnetite, electrical and / or magnetic One or more kinds of fillers such as, but not limited to, a material exhibiting general permeability and heat conductivity (for example, hematite) and / or hydroxyapatite may be used. The filler can take any shape to suit the desired application of the perfluoropolymer, but is generally in a particulate form.

  The term “functional additive” refers herein to a material that is added to a process that performs a specific function. Examples of such additives include interaction agents (co-agents), processing aids, curatives and / or plasticizers, or other known additives or Examples include, but are not limited to, additives developed in the perfluoroelastomer technology, such as acid acceptors, cure accelerators, and glass fibers. Or, polyaramid fibers such as Kevlar (R). Examples of plasticizers useful in current perfluoropolymer materials include perfluorinated alkyl ethers such as Krytox® available from du Pont. alkyl ether, perfluoropolyether oil commercially available from Daikin, and other perfluoropolyether oils from Ausimont in Italy Fomblin (registered trademark), and most preferred is Demnum (registered trademark) S-100.

  In general, any additive is present in the mixture in an amount of about 25% by weight, based on the weight of the perfluoropolymer in the perfluoropolymer material.

  The substrate used in the process of the present invention can be any suitable material, either porous or non-porous, or durable, sacrificial. There may be. For example, the substrate may be a metallic mandrel, a non-metallic mandrel, a metallic implant, or a non-metallic implant. Suitable materials for the substrate include, but are not limited to, steel, stainless steel, glass, PTFE or ePTFE. Whether the substrate is porous depends on the application in which the product is used.

  There are many methods that can be used in step (iii) to apply the mixture obtained from steps (i) and (ii) to a substrate to form one or more deposited layers. These methods are: Pneumatic spraying, Electrostatically focused pneumatic spraying, Electrospraying, Ultrasonic spraying, Syringing, Electrospinning (Electrostatic spinning), Inkjet printing, Dip coating, Brushed / painted, other processing methods that can be used to apply solutions or liquid mixtures, including these It is not limited to things.

  In general, the method used to apply the mixture to the substrate is a spraying technique, the most typical being Pneumatic spraying.

  Many layers may be deposited on the substrate as desired. In general, a plurality of layers are provided. The thickness of each layer deposited on the substrate is typically less than about 10 microns. A thick layer of coating can be constituted by multiple depositions. It should be noted that the composition of each successive layer of multiple depositions may be a different perfluoropolymer mixture if desired.

  In step (iv), energy is applied to the substrate or the one or more deposition layers, and the temperature of the one or more deposition layers evaporates the one or more perfluorosolvents in step (i), at least in part. By raising the temperature to a temperature sufficient to desolvate the layer, the solvent is at least partially removed from the one or more deposited layers. The energy is typically supplied using direct heating (directional heating). This means that one side has a surface to prevent or minimize the formation of bubbles on the perfluoropolymer material and to prevent or minimize the formation of other undesirable defects. It means making it hotter than the other side. Application of sufficient energy to raise the temperature above the highest boiling point of the one or more perfluorosolvents in step (i) is not necessary to remove the solvent from the substrate or one or more deposited layers. Although temperatures below the level will effectively remove the solvent, in general, the temperature of the substrate or one or more of the deposited layers will cause the highest boiling point of the one or more perfluorosolvents in step (i). It will be understood that the temperature rises above. Furthermore, if desired, the heating step (iv) may be repeated as necessary.

  When perfluoroelastomer materials are cured, there are three proven mechanisms for the cross-linking of perfluoropolymers used in the curing process of these materials.

  Diamine cross-linking using blocked diamine. In the presence of basic media, monomers such as vinylidene fluoride are vulnerable to dehydrofluorination that allows the addition of diamines to the polymer chain. In general, magnesium oxide is used to scavenge the resulting hydrofluoric acid to produce magnesium fluoride and water. Diamine curing exhibits superior rubber-to-metal bonding properties compared to other cross-linking mechanisms.

  Ionic cross-linking (dihydroxy cross-linking). Ionic cross-linking exhibits superior heat resistance, improved hydrolytic stability, and excellent compression set compared to diamine curing. In contrast to diamine curing, the ionic mechanism is not an addition mechanism, but an aromatic nucleophilic substitution mechanism. Dihydroxy aromatic compounds are used as crosslinkers, and generally tetravalent phosphonium salts are used to accelerate the curing process.

  Peroxide crosslinking that proceeds through the free radical mechanism. Peroxide crosslinking is a system often chosen in water and non-aqueous electrolytes.

  Generally, the substrate is heated while the mixture from steps (i) and (ii) is deposited on the substrate. When multiple stacks are deposited on a substrate, it is desirable that the perfluorosolvent be substantially removed from each layer before the next layer is deposited. Preferably, evaporation at room temperature is used to avoid the use of heat. After the semi-solid matrix is formed by this solvent removal step and the matrix is cured, the porogen may be removed from the solid matrix. This step can be accomplished by using a liquid or gaseous vehicle. While this medium is inert to the perfluoropolymer in the perfluoropolymer material, it can react, dissolve and / or ionic bond with the porogen to remove the porogen from the matrix. Most preferably, the porogen is removed from the solid matrix by washing with water or dilute acid such as Bronsted acid. Bronsted acids include hydrochloric acid, nitric acid or sulfuric acid, or conventional alcohols. A considerably hardened solid matrix will naturally reduce in hardness and become softer, more flexible and elastic once the porogen is removed. In general, the perfluoropolymer material may be cured using the preferred temperature or other curing conditions for the particular perfluoropolymer material and curing system. Curing may optionally include post curing steps for such compositions, if desired. After curing and subsequent porogen removal, a porous perfluoropolymer with a large number of open cells is formed.

  The material is molded, transferred molded, compression molded, extruded, etc., cured, and then subjected to a porogen removal process. Various extraction techniques can be used provided that the porogen can be substantially removed, more preferably completely removed. Of course, the order and specific steps for molding, curing, molding and / or extraction of materials will vary as long as the perfluoropolymer material is cured and the porogen is extracted from the perfluoropolymer material. May be.

  The perfluoropolymer material has a strong structural integrity even before the curing step (v) is performed.

  The curing temperature of the perfluoropolymer material will vary depending on the type of composition used as well as the curing system. It will be appreciated by those skilled in the art that curing conditions vary with different elastomeric systems and such perfluoropolymer materials begin to cure at temperatures above about 280 ° F. (138 ° C.). If higher temperatures are supplied, a faster cure time is achieved, but care must be taken not to use excessively high cure temperatures to cause thermal degradation of the substrate.

  The heat applied can be applied using a variety of heat sources, such as heat generated from heated molds, curing ovens, radiant energy, exothermic reactions, or heat generated from other heat exchange systems. . Preferably, the term “heating” as used herein refers to any application of heat, radiant energy or ideally any other form of energy that can remove the solvent at a fast rate and / or cure the perfluoropolymer material ( However, in general, the substrate is heated using either inductive heating, convective heating or conductive heating. Uses a hot zone that induces evaporation of the solvent from the deposited layer, where conductive heating heats the substrate in a conductive manner, creating hotter regions, or via radiative heating. Or through a combination of two or more of these heating methods, inductive heating is preferably non-contact, When granulation is more preferable.

  According to another aspect of the present invention, there is provided a perfluoroelastomer product produced by the method described above.

  According to another aspect of the present invention, there is provided the use of a perfluoroelastomer product in a medical device produced by the above-described method, for use as a medical device, such as an implant, a graft, an insertable medical device, Regenerative medical products using cardiac artificial blood vessels, grafts, synthetic lattices (functioning as scaffolds for human or animal cell growth in the scaffold), sutures, sealing members, fuel cell members, or , Coatings on orthopedic implants.

  It goes without saying that the above-described specific embodiments can be changed by those skilled in the art within the scope of the present invention. Accordingly, the present invention is not intended to be limited to the specific forms disclosed, but is intended to be modified within the scope of the invention as defined in the appended claims.

Claims (20)

A method of processing a perfluoropolymer material, the processing method comprising:
i) dissolving one or more uncured perfluoropolymer materials in a solvent comprising one or more liquid perfluorosolvents to form a solution;
ii) optionally adding one or more porogens and / or one or more functional additives to the solution formed in step (i) to form a mixture;
iii) applying the solution or mixture formed in steps (i) and (ii) to a substrate to form a partially or continuous one or more deposited layers on the substrate;
iv) applying a predetermined amount of energy to the substrate or the one or more deposited layers to at least partially remove the solvent from the one or more deposited layers;
v) curing the perfluoropolymer material in the one or more deposited layers to form a perfluoroelastomer product;
vi) optionally removing the one or more porogens from the perfluoroelastomer product;
A process for the treatment of perfluoropolymer materials comprising:   The perfluoroelastomer material is one or more selected from tetrafluoroethylene (TFE), hexafluoropropylene (HFP), and perfluoroalkyl vinyl ethers (PAVEs), or perfluoroalkyl vinyl ether. Processing method.   The perfluoroalkyl vinyl ether contains a linear or branched alkyl group and contains one or more ether bonds selected from perfluoro (methyl vinyl ether), perfluoro (ethyl vinyl ether), and perfluoro (propyl vinyl ether). The processing method according to claim 2.   The perfluoroelastomer material comprises a terpolymer of tetrafluoroethylene, a perfluoroalkyl vinyl ether, and at least one perfluorinated cure site monomer comprising functional groups that allow crosslinking of the terpolymer. 2. The processing method according to 1.   The processing method according to claim 4, wherein the cure site monomer contains a functional group of cyano, bromo, iodo or pentafluorophenoxy.   The one or more porogens include sodium chloride, salicylic acid, lactose, valine, sodium bicarbonate, sodium bicarbonate, calcium carbonate, glycine, polyethylene oxide, polyethylene glycol (PEG), polyvinylpyrrolidone, particulate polymer, polyvinyl chloride and / or The treatment method according to claim 1, wherein the treatment method is at least one material selected from titanium dioxide.   The treatment according to any one of claims 1 to 6, wherein the one or more porogens are present in an amount of from about 10 to about 500 parts by weight per 100 parts by weight of the perfluoropolymer in the perfluoropolymer material. Method.   The processing method according to claim 1, further comprising a step of removing the one or more porogens from the cured perfluoroelastomer material.   The functional additive is one or more selected from an interactive agent, a processing aid, a filler, an acid acceptor, a curing accelerator, glass fiber, polyaramid fiber, a curing agent and / or a plasticizer. 9. The processing method according to any one of 8 above.   The processing method according to claim 1, wherein the substrate is a metallic mandrel, a nonmetallic mandrel, a metallic implant, or a nonmetallic implant.   The processing method according to claim 1, wherein a plurality of layers are deposited on the substrate.   In the step (iii), the mixture obtained from the steps (i) and (ii) is subjected to pressure blowing, electrostatically squeezed pressure blowing, electrospray, ultrasonic spraying, injection, electrostatic spinning, The processing method according to any one of claims 1 to 11, wherein the substrate is applied by a method selected from ink jet printing, dip coating, and polishing / painting.   The processing method according to claim 1, wherein in the step (iv), the substrate is heated by a direct heating device.   The processing method according to any one of claims 1 to 13, wherein only one kind of the solvent is used in the step (i).   The processing method according to claim 1, wherein the solvent is substantially completely removed.   The processing method according to any one of claims 1 to 15, wherein the step (v) of curing the perfluoropolymer is performed when the perfluoropolymer is on the substrate.   The processing method according to any one of claims 1 to 15, wherein the step (v) of curing the perfluoropolymer is performed when the perfluoropolymer is not on the substrate.   A perfluoroelastomer product produced by the processing method according to claim 1.   Use of a perfluoroelastomer product provided by claim 18 in a medical device, in a sealing member, in a fuel cell member or as a coating on an orthopedic implant.   A processing method, product or use substantially as herein described.